近日，上海市肺科医院Caicun Zhou等研究人员完成serplulimab加化疗作为晚期鳞状非小细胞肺癌一线治疗的全球3期研究（ASTRUM-004）。相关论文于2024年1月4日在线发表于国际学术期刊《癌细胞》。

研究人员表示，对于无靶向基因改变的晚期鳞状非小细胞肺癌（NSCLC）患者来说，将免疫疗法与化疗相结合可提高生存率。537名既往未接受过治疗的IIIB/IIIC或IV期无靶向基因改变的鳞状NSCLC患者被纳入研究，并随机（2:1）接受4.5 mg/kg的serplulimab或安慰剂治疗，两种药物均与纳布-紫杉醇和卡铂联合使用，静脉滴注，3周为一个周期。在第一次中期分析中，无进展生存期（PFS）这一主要终点已经达到。

在第二次中期分析中，serplulimab化疗组的无进展生存期获益得以维持（危险比[HR]0.53，95%置信区间[CI]0.42-0.67）。在最终分析中，与安慰剂化疗组相比，serplulimab化疗组显著改善了中位OS（HR 0.73，95% CI 0.58-0.93；P=0.010）。分别有126例（35.2%）和58例（32.4%）患者发生了≥3级的serplulimab或安慰剂相关不良事件。

这些研究结果表明，在化疗中加入serplulimab可显著提高晚期鳞状NSCLC患者的生存率，且安全性可控。

附：英文原文

Title: A global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004)

Author: Caicun Zhou, Yanping Hu, Ekaterine Arkania, Saadettin Kilickap, Kejing Ying, Fei Xu, Lin Wu, Xiang Wang, Maksym Viguro, Tamta Makharadze, Hongmei Sun, Feng Luo, Jianhua Shi, Aimin Zang, Yueyin Pan, Zhendong Chen, Zhongyao Jia, Vladimer Kuchava, Ping Lu, Ling Zhang, Ying Cheng, Wenying Kang, Qingyu Wang, Haoyu Yu, Jing Li, Jun Zhu

Issue&Volume: 2024-01-04

Abstract: Combining immunotherapy with chemotherapy can provide improved survival in advancedsquamous non-small-cell lung cancer (NSCLC) patients without targetable gene alterations.537 previously untreated patients with stage IIIB/IIIC or IV squamous NSCLC withouttargetable gene alterations were enrolled and randomized (2:1) to receive serplulimab4.5 mg/kg or placebo, both in combination with nab-paclitaxel and carboplatin, intravenouslyin 3-week cycles. The primary endpoint of progression-free survival (PFS) was metat the first interim analysis. At the second interim analysis, PFS benefit was maintainedin serplulimab-chemotherapy group (hazard ratio [HR] 0.53, 95% confidence interval[CI] 0.42–0.67). At the final analysis, serplulimab-chemotherapy significantly improvedmedian OS compared to placebo-chemotherapy (HR 0.73, 95% CI 0.58–0.93; p = 0.010).Grade ≥3 serplulimab or placebo-related adverse events occurred in 126 (35.2%) and58 (32.4%) patients, respectively. Our results demonstrate that adding serplulimabto chemotherapy significantly improves survival in advanced squamous NSCLC patients,with manageable safety.

DOI: 10.1016/j.ccell.2023.12.004

Source: https://www.cell.com/cancer-cell/fulltext/S1535-6108(23)00432-4